6.1 Trial Termination A data safety group with members that have expertise in biostatistics, neonatology, clinical pharmacology, and pediatric infectious disease will monitor the data during the study for AEs, patient safety, and potential toxicity. If two subjects develop an unexpected SAE related to study drug, we will stop enrollment to evaluate the data and safety of the product in this population. Dr. Brian Smith (neonatologist) will receive SAEs and call ad hoc meetings of the safety group as needed.